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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT 2009-010295-23 |
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The aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty.
This study will enroll STEMI patients, who were planned to undergo PCI, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg or 900 mg. Platelet activity after administration of clopidogrel will be evaluated by VerifyNow™ P2Y12 point-of-care system.
The study is powered to demonstrate significant differences in the primary end point (the rate of TIMI Myocardial Perfusion Grade=3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no pre-treatment | Other | No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting |
|
| 600 mg loading dose | Experimental | 600 mg clopidogrel loading dose at first medical contact |
|
| 900 mg loading dose | Experimental | 900 mg clopidogrel loading dose at first medical contact |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel 300 mg | Drug | Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| TIMI Myocardial Perfusion Grade (TMPG) | post-PCI |
| Measure | Description | Time Frame |
|---|---|---|
| TIMI flow | pre- and post-PCI | |
| Corrected TIMI Frame Count (cTFC) | post-PCI | |
| Major bleedings |
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Inclusion Criteria:
ST-elevation myocardial infarction:
With indication to primary PCI, presenting within 12 hour from symptoms onset
Age > 18 years
Planned PCI
Informed Consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo Bolognese, MD, FESC | Ospedale San Donato | Principal Investigator |
| Kenneth Ducci, MD | Ospedale San Donato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Department, Ospedale S.Donato | Arezzo | AR | 52100 | Italy |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Clopidogrel 600 mg | Drug | Patients will receive a 600 mg clopidogrel loading dose at first medical contact |
|
|
| Clopidogrel 900 mg | Drug | Patients will receive a 900 mg clopidogrel loading dose at first medical contact |
|
|
| 30 days |
| Major adverse cardiac events (MACEs) | 30 days |
| Platelet Reactive Units (PRU) as assessed by VerifyNow™ System | pre-PCI |
| TIMI 2-3 grade flow of the infarct-related artery | pre-PCI |
| no reflow phenomenon | post-PCI |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |